- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07631390
Impact of Task-Specific Electrical Stimulation on Upper Limb Functional Motor Skills in Children With Spastic Quadriplegia
연구 개요
상태
상세 설명
Cerebral palsy (CP) encompasses a clinically diverse group of permanent but non-progressive disorders of posture and movement caused by disturbances in the developing brain (Rosenbaum et al., 2007). Spastic quadriplegia, also known as spastic tetraplegia, is a major subtype of spastic CP, characterized by significant impairment in motor function involving all four limbs and the trunk. Unlike spastic hemiplegia, which affects one side of the body, or spastic diplegia, which predominantly involves the lower limbs, spastic quadriplegia is defined by the bilateral and symmetric involvement of upper and lower extremities-often with the upper limbs being as severely, or more severely, affected than the lower extremities (Beckung et al., 2007; Palisano et al., 2009). Spastic quadriplegia is considered the most severe form of CP. Epidemiological data indicate that this subtype accounts for approximately 20-30% of all children with CP, with some variability by region and study population (Beckung et al., 2007). The condition affects both males and females and is not limited to any particular ethnic or socioeconomic group. 2. Etiology and Pathophysiology The etiology of spastic quadriplegia is multifactorial, primarily involving prenatal, perinatal, or early postnatal injury to the developing brain. The most common causes include:
- Prenatal factors: Intrauterine infections, genetic abnormalities, placental insufficiency, and exposure to toxins.
- Perinatal factors: Birth asphyxia, prematurity, intracranial hemorrhage, and periventricular leukomalacia (PVL).
- Postnatal factors: Neonatal stroke, traumatic brain injury, severe infections (e.g., meningitis, encephalitis). Brain imaging in children with spastic quadriplegia frequently reveals extensive lesions, often affecting both cortical and subcortical structures, periventricular white matter, and the basal ganglia. Lesions are typically bilateral and may include multicystic encephalomalacia or severe PVL (Rosenbaum et al., 2007; Novak et al., 2013). The widespread nature of 24 the injury explains the symmetric involvement of all limbs and the profound motor deficits observed in this population. The pathophysiology underlying spasticity includes disruption of descending inhibitory pathways, particularly those modulating the stretch reflex, resulting in increased muscle tone, hyperreflexia, and reduced reciprocal inhibition (Damiano, 2006). 3. Clinical Features The hallmark of spastic quadriplegia is the presence of bilateral spasticity affecting both upper and lower limbs, with notable involvement of the trunk and orofacial muscles in many cases. Clinical manifestations include:
- Severe motor impairment: Marked spasticity, muscle weakness, and decreased selective voluntary motor control in all extremities (Beckung et al., 2007).
- Joint contractures and deformities: Chronic spasticity often leads to fixed contractures, particularly at the shoulders, elbows, wrists, hips, knees, and ankles.
- Postural instability: Poor trunk and head control, often resulting in scoliosis, pelvic obliquity, and difficulties with sitting balance.
- Abnormal movement patterns: Persistence of primitive reflexes, synergistic patterns, and lack of dissociated movements.
- Oromotor and bulbar involvement: Dysarthria, drooling, and feeding difficulties are common due to spasticity of facial and bulbar muscles.
- Associated impairments: Cognitive impairment, epilepsy, sensory deficits (visual and auditory), and behavioral problems occur at higher rates in this population (Palisano et al., 2009; Novak et al., 2013). 4.Upper Limb Function in Spastic Quadriplegia Impairment of upper limb function is a cardinal feature and a primary determinant of disability in spastic quadriplegia. Key features include:
- Spasticity and weakness: Typically most pronounced in the flexor muscles of the upper limbs (shoulder adductors, elbow flexors, wrist and finger flexors).
- Impaired selective motor control: Difficulty isolating joint movements leads to mass grasp and release patterns, limiting dexterity and functional hand use (DeMatteo et al., 1992).
- Contractures: Especially common at the elbows and wrists, further limiting range of motion and functional reach.
- Poor postural control: Inadequate trunk stability compromises the ability to use the arms for support or manipulation.
- Functional impact: Profound limitations in reaching, grasping, releasing, weight-bearing, and manipulating objects undermine the ability to perform self-care, use assistive devices, participate in play and education, and interact socially (Palisano et al., 2009). Task-Specific Electrical Stimulation (TASES) Task-specific electrical stimulation (TASES) represents a significant evolution in the application of neurostimulation in neurorehabilitation. Unlike traditional NMES or FES, which may be applied passively or in a cyclic fashion, TASES is explicitly synchronized with active, goal directed motor tasks to maximize the interplay between voluntary effort and afferent feedback (Gordon et al., 2013; Daly et al., 2006). This approach is rooted in the principles of motor learning and neuroplasticity, which posit that the repetition of meaningful, contextually relevant tasks fosters more robust and lasting changes in the central nervous system than passive exercise alone (Kleim & Jones, 2008; Nudo, 2006). Principles and Mechanisms The primary premise of TASES is that coupling electrical stimulation with volitional, task-driven movement enhances motor output by:
- Increasing sensory feedback during task execution, thereby strengthening sensorimotor integration
- Facilitating the recruitment of motor units that might otherwise be difficult to activate voluntarily, especially in paretic or spastic muscles
- Reinforcing the temporal and spatial patterns of muscle activation required for functional tasks 40 By delivering stimulation at key points during a task (for example, during the weight-bearing phase of a push-up or during wrist extension as the hand contacts a support surface), TASES can help children with severe motor impairments more effectively engage muscles critical for upper limb function (Gordon et al., 2013; Daly et al., 2006). Mechanisms Underlying Functional Improvements Understanding the mechanisms by which electrical stimulation, and specifically task-specific electrical stimulation (TASES), improves upper limb function in children with spastic quadriplegia is essential for optimizing therapy and advancing clinical practice. The effects of ES are multifaceted, involving changes at the muscular, neural, and behavioral levels.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Egypt
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Alexandria, Egypt, 이집트, 21515
- Aalaa Ahmed Farrag
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Their age will be ranged from 4 to 7 years.
- Their grade of spasticity will be from 1+ to 2 according to Modified Ashworth scale
- They will be on Level III and IV according to Gross Motor Functional Classification System (GMFCS).
- Parents/legals representatives consenting to their child's participation
- Diagnosed with Spastic Quadriplegic cerebral palsy
Exclusion Criteria:
- Previous neurological or orthopedic surgery in the upperextremities.
- Fixed deformity in the joints of upper limb. 3- Severe hearing and visual defect.
4-Irregular attendance at assessments or therapy sessions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Study group
Task-specific electrical stimulation, was delivered using the NMES (Neuromuscular Electrical Stimulation) mode on the Chattanooga ContinuumTM Portable two channel electrical stimulator. • This device is commonly used for muscle re-education, strengthening and functional rehabilitation. Every kid received three sessions per week for two months; each session lasted one hour, half an hour was for the designed physiotherapy program (as in the control group), and last 20 minutes was for the TASES application during the weight bearing exercises including push up exercise, prone on hands exercise, quadruped with weight shifting, in addition to transition activities as side sitting to quadruped exercise. |
이 프로그램은 개방형 및 폐쇄 체인 운동의 조합을 사용했습니다.
손 무게 베어링과 함께 앉아 앉기위한 앙와위로, 측면에 누워 앉아, 측면에 앉아, 웨지에 손에 닿기 쉬운 웨이트 베어링 운동, 체중 이동으로 4 배나 운동을하고 운동을 한 시간 동안 밀어 올리는 운동.
The Chattanooga Continuum™ (fig.2) is a portable 2 channel stimulator used by therapists in clinics and patients at home to provide electrical stimulation treatments in pain management (TENS) and neuromuscular stimulation (NMES).
By combining TENS with NMES, users can simultaneously help manage pain and enhance exercise,3 thereby shortcutting the traditional muscle recovery cycle.
Factor in a choice of program options including customizable waveforms,and you have a highly versatile and user-friendly rehabilitation tool that can help deliver optimal therapeutic outcomes.
The Continuum Kit includes a transportation pouch and hand switch.
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활성 비교기: Control group
Every kid received three sessions per week for two months; each session lasted one hour of designed physiotherapy program which included upper limb weight bearing exercises
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이 프로그램은 개방형 및 폐쇄 체인 운동의 조합을 사용했습니다.
손 무게 베어링과 함께 앉아 앉기위한 앙와위로, 측면에 누워 앉아, 측면에 앉아, 웨지에 손에 닿기 쉬운 웨이트 베어링 운동, 체중 이동으로 4 배나 운동을하고 운동을 한 시간 동안 밀어 올리는 운동.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Improved upper limb functional motor skills
기간: 2 months after treatment
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The Quality of Upper Extremity Skills Test (QUEST) is used by assessment of the weight bearing domain
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2 months after treatment
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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